BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPINER MEDICAL LTD PRODUCT CODE EMP100WG

    MDR report key: 4785325 · Received May 5, 2015

    Report

    Report Number
    3003895717-2015-00001
    Event Type
    Injury
    Date Received
    May 5, 2015
    Date of Event
    March 28, 2014
    Report Date
    March 31, 2015
    Manufacturer
    ESPINER MEDICAL LTD.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE (REMOVAL OF AN OVARIAN CYST) IN THE (B)(6), A FRAGMENT OF PLASTIC FROM THE INTRODUCER ARM OF THE AUTOMATIC TISSUE RETRIEVAL SAC WAS SHEARED FROM ONE OF THE ARMS. THIS WAS NOTICED DURING FLUSHING OF THE SURGICAL SITE AND REMOVED BY THE SURGEON USING STANDARD GRASPERS. THE PROBLEM WAS CAUSED BY INCORRECT USE OF THE DEVICE BY THE SURGEON, WHO WITHDREW THE PLASTIC DEVICE INTRODUCER ROD BY FORCING IT BACK INTO THE SHARP EDGE OF THE TROCAR WHICH IN TURN CUT INTO THE PLASTIC ARM. (THERE WERE 2 INSTANCES REPORTED BY THE SAME HOSPITAL/SURGEON WITHIN A TWO WEEK PERIOD) THE INFORMATION FOR USE LABEL CLEARLY SHOWS THAT THE PLASTIC DEVICE INTRODUCER ROD SHOULD BE WITHDRAWN INTO THE PLASTIC DELIVERY TUBE WHICH IS AN INTEGRAL PART OF THE DEVICE. IN ADDITION TO THE DESIGN MODIFICATIONS MADE TO THE TISSUE RETRIEVAL SAC, THE PLASTIC ARMS HAVE ALSO BEEN MODIFIED TO REMOVE THE STRENGTHENING LIP ON THE ARM THAT IS SHEARING OFF. THIS HAS INVOLVED MODIFYING THE INJECTION MOULDING TOOL AND THIS TOOK EFFECT ON (B)(6) 2014. THESE 2 MODIFICATIONS, FURTHER REMOVE THE POSSIBILITY OF THIS TYPE OF DEVICE FAILURE. NO FURTHER INSTANCES OF THIS TYPE OF FAILURE HAVE BEEN REPORTED SINCE. THE DEVICE FAILURES HAVE REMAINED AS BEING CAUSED BY ONE SURGEON IN ONE UK HOSPITAL. REFERENCE MFR # 3009231402-2015-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295836 ESPINER MEDICAL LTD PRODUCT CODE EMP100WG TISSUE RETRIEVAL SYSTEM GCJ ESPINER MEDICAL LTD. EMP100WG LT10/13-A1602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention